Clinical Trials Directory

Trials / Terminated

TerminatedNCT03123159

Clinical Performance Evaluation of DxN HBV Assay

Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy

Status
Terminated
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Beckman Coulter, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers

Summary

The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.

Detailed description

Same as brief summary.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTDxN HBV AssayMolecular diagnostic test to detect Hepatitis B

Timeline

Start date
2014-05-27
Primary completion
2017-08-30
Completion
2017-08-30
First posted
2017-04-21
Last updated
2018-07-12

Locations

10 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT03123159. Inclusion in this directory is not an endorsement.